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Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants
Sponsor: Il-Yang Pharm. Co., Ltd.
Summary
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)
Official title: Phase Ⅲ, Randomized, Double-blind, Active Controlled to Evaluate the Immunogenicity and Safety of "IL-YANG Quadrivalent Seasonal Influenza Vaccine" in Healthy Infants From 6 Months to Under 3 Years of Age(≥ 6 Months and < 3 Years)
Key Details
Gender
All
Age Range
6 Months - 3 Years
Study Type
INTERVENTIONAL
Enrollment
245
Start Date
2024-10-23
Completion Date
2026-05-31
Last Updated
2026-03-25
Healthy Volunteers
Yes
Conditions
Interventions
IL-YANG FLU Vaccine Prefilled Syringe INJ.
Teratect Prefilled Syringe Inj. 0.5mL
Fluarix Tetra Pre-filled Syringe
Fluarix Tetra Pre-filled Syringe 0.5mL
Locations (2)
Korea University ANSAN Hospital
Ansan-si, Gyeonnggi-do, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonnggi-do, South Korea